WHFM/MS-DIARY: An Integrated Wearable Hot Flash Monitor and Portable Electronic D

WHFM/MS-DIARY：集成可穿戴式潮热监测器和便携式电子 D

• 批准号: 7243107
• 负责人: RANGA NARAYANASWAMI
• 金额: $ 23.83万
• 依托单位: METIS DESIGN CORPORATION
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7243107
• 关键词: clinical research; conditioning; hot flash; menopause; skin

DESCRIPTION (provided by applicant): WHFM/MS-DIARY: An Integrated Wearable Hot Flash Monitor and Portable Electronic Diary for Menopausal Symptomatology: Summary: The majority of American women transitioning through the menopause will experience hot flashes and night sweats. These vasomotor symptoms are the leading cause of treatment-seeking among menopausal women. With recent results of the Women's Health Initiative, many women are looking for non-hormonal ways to manage their vasomotor and other menopause related symptoms. This has resulted in increased attention to studying complementary and alternative treatments for these symptoms. However, the field is currently limited by lack of instruments and devices that capture both objective and subjective measures of menopausal symptoms for use in clinical studies under ambulatory conditions. Sternal skin conductance devices are well suited for use in ambulatory settings to capture frequency data on hot flashes. Metis Design Corporation is currently developing a wearable sternal skin conductance device for ambulatory hot flash monitoring. This device, as well as others, however, are not able to capture all dimensions of hot flashes, such as intensity and interference with daily life. Moreover, other symptom domains of menopause, such as affective, somatic and urogenital symptoms remain uncaptured. Various questionnaires and diaries have been used in earlier studies of menopause, but not many have been validated. Further, there is a paucity of data on automated data collection used in clinical studies of menopause through computer assisted self interviews. Improved instruments and devices that collect self reported data on the broader symptoms of menopause would be very beneficial for future clinical trials of CAM therapies. The goal of this application is to develop an integrated device that records objective measures of hot flashes using a wearable sternal skin conductance device and collects and stores self-reported data on menopausal symptoms. The integrated sternal skin conductance device and electronic diary for self-reported menopausal symptoms will be developed by Metis Design Corporation. The device will be clinically validated at Wake Forest University School of Medicine. A wearable hot flash monitor (WHFM) records skin conductance and an electronic diary records menopausal symptomatologies (MS-DIARY). The integrated system is referred to as WHFM/MS-DIARY. Questions that capture all dimensions of symptoms associated with menopause will be developed. An electronic dairy to record menopausal symptomatology will be developed. The electronic diary will be integrated tightly with WHFM using time stamping. The WHFM/MS-DIARY will be pilot tested under ambulatory conditions. Subsequent steps to refine and improve these systems will be determined. Economies of scale will be explored for producing large number of devices for large scale clinical trials. WHFM/MS-DIARY: An Integrated Wearable Hot Flash Monitor and Portable Electronic Diary for Menopausal Symptomatology: Narrative: The majority of American women transitioning through the menopause will experience hot flashes and night sweats. These vasomotor symptoms are the leading cause of treatment-seeking among menopausal women. With recent results of the Women's Health Initiative, many women are looking for non-hormonal ways to manage their vasomotor and other menopause related symptoms. This has resulted in increased attention to studying complementary and alternative treatments for these symptoms. However, the field is currently limited by lack of instruments and devices that capture both objective and subjective measures of menopausal symptoms for use in clinical studies under ambulatory conditions. Sternal skin conductance devices are well suited for use in ambulatory settings to capture frequency data on hot flashes. Metis Design Corporation is currently developing a wearable sternal skin conductance device for ambulatory hot flash monitoring. This device, as well as others, however, are not able to capture all dimensions of hot flashes, such as intensity and interference with daily life. Moreover, other symptom domains of menopause, such as affective, somatic and urogenital symptoms remain uncaptured. Various questionnaires and diaries have been used in earlier studies of menopause, but not many have been validated. Further, there is a paucity of data on automated data collection used in clinical studies of menopause through computer assisted self interviews. Improved instruments and devices that collect self reported data on the broader symptoms of menopause would be very beneficial for future clinical trials of CAM therapies. The goal of this application is to develop an integrated device that records objective measures of hot flashes using a wearable sternal skin conductance device and collects and stores self-reported data on menopausal symptoms. The integrated sternal skin conductance device and electronic diary for self-reported menopausal symptoms will be developed by Metis Design Corporation. The device will be clinically validated at Wake Forest University School of Medicine. A wearable hot flash monitor (WHFM) records skin conductance and an electronic diary records menopausal symptomatologies (MS-DIARY). The integrated system is referred to as WHFM/MS-DIARY. Questions that capture all dimensions of symptoms associated with menopause will be developed. An electronic dairy to record menopausal symptomatology will be developed. The electronic diary will be integrated tightly with WHFM using time stamping. The WHFM/MS-DIARY will be pilot tested under ambulatory conditions. Subsequent steps to refine and improve these systems will be determined. Economies of scale will be explored for producing large number of devices for large scale clinical trials.

描述（由申请人提供）：WHFM/MS-DIARY：一种用于月经症状学的集成可穿戴式潮热监测仪和便携式电子日记：总结：大多数美国女性在更年期过渡时会出现潮热和盗汗。这些血管扩张症状是绝经期妇女寻求治疗的主要原因。随着妇女健康倡议的最新结果，许多妇女正在寻找非激素的方法来管理他们的血管扩张和其他更年期相关症状。这导致人们越来越关注研究这些症状的补充和替代治疗。然而，该领域目前受到缺乏仪器和设备的限制，这些仪器和设备可以捕获更年期症状的客观和主观测量值，用于在门诊条件下进行临床研究。胸骨皮肤电导装置非常适合在流动环境中使用以捕获关于潮热的频率数据。Metis设计公司目前正在开发一种用于动态潮热监测的可穿戴胸骨皮肤电导装置。然而，该设备以及其他设备不能捕获潮热的所有维度，例如强度和对日常生活的干扰。此外，更年期的其他症状领域，如情感，躯体和泌尿生殖系统症状仍然没有捕获。在早期的更年期研究中使用了各种问卷和日记，但没有多少得到验证。此外，通过计算机辅助自我访谈进行的绝经期临床研究中使用的自动数据收集数据很少。改进的仪器和设备，收集自我报告的数据，更广泛的更年期症状将是非常有益的，为未来的临床试验CAM疗法。本申请的目的是开发一种集成设备，该设备使用可穿戴胸骨皮肤电导设备记录潮热的客观测量值，并收集和存储关于更年期症状的自我报告数据。Metis Design Corporation将开发用于自我报告绝经期症状的集成胸骨皮肤电导装置和电子日记。该器械将在维克森林大学医学院进行临床验证。可穿戴式潮热监测器（WHFM）记录皮肤电导，电子日记记录绝经期的绝经情况（MS-DIARY）。集成系统称为WHFM/MS-DIARY。将开发捕获与更年期相关的症状的所有维度的问题。将开发一个记录绝经期妇女病的电子日记。电子日记将使用时间戳与WHFM紧密结合。WHFM/MS-DIARY将在非卧床条件下进行试点测试。将确定今后改进和提高这些制度的步骤。将探索规模经济，以生产用于大规模临床试验的大量器械。WHFM/MS-日志：一个综合的可穿戴的潮热监测器和便携式电子日记的月经症状：叙述：大多数美国妇女过渡到更年期将经历潮热和盗汗。这些血管扩张症状是绝经期妇女寻求治疗的主要原因。随着妇女健康倡议的最新结果，许多妇女正在寻找非激素的方法来管理他们的血管扩张和其他更年期相关症状。这导致人们越来越关注研究这些症状的补充和替代治疗。然而，该领域目前受到缺乏仪器和设备的限制，这些仪器和设备可以捕获更年期症状的客观和主观测量值，用于在门诊条件下进行临床研究。胸骨皮肤电导装置非常适合在流动环境中使用以捕获关于潮热的频率数据。Metis设计公司目前正在开发一种用于动态潮热监测的可穿戴胸骨皮肤电导装置。然而，该设备以及其他设备不能捕获潮热的所有维度，例如强度和对日常生活的干扰。此外，更年期的其他症状领域，如情感，躯体和泌尿生殖系统症状仍然没有捕获。在早期的更年期研究中使用了各种问卷和日记，但没有多少得到验证。此外，通过计算机辅助自我访谈进行的绝经期临床研究中使用的自动数据收集数据很少。改进的仪器和设备，收集自我报告的数据，更广泛的更年期症状将是非常有益的，为未来的临床试验CAM疗法。本申请的目的是开发一种集成设备，该设备使用可穿戴胸骨皮肤电导设备记录潮热的客观测量值，并收集和存储关于更年期症状的自我报告数据。Metis Design Corporation将开发用于自我报告绝经期症状的集成胸骨皮肤电导装置和电子日记。该器械将在维克森林大学医学院进行临床验证。可穿戴式潮热监测器（WHFM）记录皮肤电导，电子日记记录绝经期的绝经情况（MS-DIARY）。集成系统称为WHFM/MS-DIARY。将开发捕获与更年期相关的症状的所有维度的问题。将开发一个记录绝经期妇女病的电子日记。电子日记将使用时间戳与WHFM紧密结合。WHFM/MS-DIARY将在非卧床条件下进行试点测试。将确定今后改进和提高这些制度的步骤。将探索规模经济，以生产用于大规模临床试验的大量器械。